O le Clarity Pharmaceuticals, o se kamupani leitio fa'afoma'i fa'ata'ita'i fa'ata'ita'i o lo'o atia'e oloa e soso'o mai e fa'atatau i le fa'atupulaia o mana'oga ile oncology, na fa'ailoa mai ua mae'a ona togafitia lona sui muamua i le vaega 2 ole 64Cu/67Cu SARTATE ™ neuroblastoma su'esu'ega (CL04) i le fa'ateleina. fua maualuga ole 175MBq/kg mamafa tino.

E leʻi leva ona agaʻi i luma le manino i le vaega 2 o le CL04 faʻataʻitaʻiga ina ua maeʻa le faʻataʻitaʻiga 1 lea na maua ai e le toʻatolu tagata auai togafitiga faʻatasi ma le 67Cu SARTATE ™ i se fua o le 75MBq / kg mamafa o le tino. Na iloiloina e le Komiti o le Saogalemu le iloiloga o faʻamaumauga mai le vaega 1 lea e leai se fua faʻatapulaʻa faʻamaʻi na tupu ma fautuaina e faʻagasolo le faʻataʻitaʻiga i le cohort 2, e aunoa ma se suiga, faʻateleina le fua ile 175MBq / kg mamafa o le tino.

Na taʻua e le Taʻitaʻifono Faʻatonu o Clarity, Dr Alan Taylor, "Matou te matua fiafia lava e faʻamaʻi le tagata maʻi muamua i le vaega 2 i la matou suʻega o le neuroblastoma togafitiga i le US, ua maeʻa faʻamaeʻaina le vaega 1 ia Ianuari 2022. 1 e taua tele i faʻamaʻi faʻamaʻi faʻamaʻi, e pei o le neuroblastoma, ma le kulupu 2 o le a vaʻaia gaioiga faʻatinoina e sili atu nai lo le faaluaina pe a faʻatusatusa i le kulupu 2. Matou te tulimatai atu i le faʻaauauina o le faʻafaigaluegaina i le vaega 1 i nofoaga uma e lima ile US, fausia i luga o le faʻamalosia faʻamatalaga muamua mai le vaega 2 ma le aoina atili o faʻamaoniga o faʻamaoniga ma togafitiga faʻapitoa o le SARTATE ™ oloa mo togafitiga o tamaiti e maua i le neuroblastoma.

Ole su'esu'ega ole CL04 ole su'esu'ega fa'ata'ita'i (diagnosis and therapy) i tamaiti ma'i e maua i le neuroblastoma maualuga (NCT04023331). O se fa'ata'ita'iga fa'apitoa e tele-centre, fa'atuputeleina o fuala'au, fa'ailoga matala, e le o fa'ata'ita'iina, Vaega 1/2a fa'ata'ita'iga fa'apitoa e o'o atu i le 34 tagata auai na faia i nofoaga fa'afoma'i e lima i le US.

O le neuroblastoma e masani ona tupu i tamaiti laiti ifo i le 5 tausaga le matutua ma e tupu pe a tupu le tuma ma mafua ai auga. O le ituaiga sili ona taatele o le kanesa e maua i le tausaga muamua o le olaga ma e tusa ma le 15% o le kanesa o tamaiti ua maliliu. E tusa ma le 45% o mataupu uma o le neuroblastoma. O tagata mama'i e maua i le neuroblastoma e maualuga le lamatiaga o lo'o i ai le maualalo o le 5-tausaga o le ola i le 40% -50%.

I le 2020, na tuʻuina atu ai e le US Food and Drug Administration (FDA) le Clarity lua Orphan Drug Designations (ODDs), tasi mo le 64Cu SARTATE ™ e avea o se suʻesuʻega faʻapitoa mo le puleaina o le neuroblastoma ma le tasi mo le 67Cu SARTATE ™ o se togafitiga o le neuroblastoma, e pei o fa'apea fo'i ma Fa'ailoga Fa'ama'i Pediatric Rare e lua (RPDDs) mo nei oloa. Afai e manuia le Clarity i le ausiaina o Talosaga Fualaau Fou a le US FDA mo nei oloa e lua, e ono mafai e RPDDs ona fa'atagaina le Kamupani e maua le aofa'i o Fa'atauga Fa'amuamua e mafai ona fefa'ataua'i (PRVs) lea na fa'atauina talu ai nei i le USD110M i le voucher.

OA MEA E AVEA MAI LENEI TUSI:

We look forward to continuing recruitment in cohort 2 at all five clinical sites in the US, building upon the encouraging initial data from cohort 1 and further gathering evidence of diagnostic and therapeutic benefits of the SARTATE™ product for the treatment of children with neuroblastoma.
In 2020, the US Food and Drug Administration (FDA) awarded Clarity two Orphan Drug Designations (ODDs), one for 64Cu SARTATE™ as a diagnostic agent for the clinical management of neuroblastoma and one for 67Cu SARTATE™ as a therapy of neuroblastoma, as well as two Rare Paediatric Disease Designations (RPDDs) for these products.
O le Clarity Pharmaceuticals, o se kamupani leitio fa'afoma'i fa'ata'ita'i fa'ata'ita'i o lo'o atia'e oloa e soso'o mai e fa'atatau i le fa'atupulaia o mana'oga ile oncology, na fa'ailoa mai ua mae'a ona togafitia lona sui muamua i le vaega 2 ole 64Cu/67Cu SARTATE ™ neuroblastoma su'esu'ega (CL04) i le fa'ateleina. fua maualuga ole 175MBq/kg mamafa tino.